Data Sharing Framework (DSF) Implementation Guide
2.0.0 - ci-build
Data Sharing Framework (DSF) Implementation Guide
2.0.0 - ci-build
Data Sharing Framework (DSF) Implementation Guide - Local Development build (v2.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Official URL: http://dsf.dev/fhir/StructureDefinition/research-study | Version: 2.0.0 | |||
| Active as of 2025-11-26 | Computable Name: ResearchStudy | |||
Usages:
You can also check for usages in the FHIR IG Statistics
Description of Profiles, Differentials, Snapshots and how the different presentations work.
| Name | Flags | Card. | Type | Description & Constraints Filter:   |
|---|---|---|---|---|
  ResearchStudy |
0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |
  meta |
Σ | 0..1 | Meta(2.0.0) | Metadata about the resource |
 implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
 modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
 status |
?!Σ | 1..1 | code | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. |
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.status | Base | required | ResearchStudyStatus | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource |
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from ResearchStudy
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| ResearchStudy |
0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |
| meta |
0..1 | Meta(2.0.0) | Metadata about the resource | |
| Documentation for this format | ||||
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchStudy |
0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta(2.0.0) | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
 extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..* | Identifier | Business Identifier for study | ||||
| title |
Σ | 0..1 | string | Name for this study | ||||
 protocol |
Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study | ||||
| partOf |
Σ | 0..* | Reference(ResearchStudy) | Part of larger study | ||||
| status |
?!Σ | 1..1 | code | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. | ||||
| primaryPurposeType |
Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study. | ||||
| phase |
Σ | 0..1 | CodeableConcept | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. | ||||
| category |
Σ | 0..* | CodeableConcept | Classifications for the study Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. | ||||
| focus |
Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding Description: (example): Codes for medications, devices and other interventions. | ||||
| condition |
Σ | 0..* | CodeableConcept | Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
| contact |
Σ | 0..* | ContactDetail | Contact details for the study | ||||
| relatedArtifact |
0..* | RelatedArtifact | References and dependencies | |||||
| keyword |
Σ | 0..* | CodeableConcept | Used to search for the study Binding Description: (example): Words associated with the study that may be useful in discovery. | ||||
| location |
Σ | 0..* | CodeableConcept | Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use. | ||||
| description |
0..1 | markdown | What this is study doing | |||||
| enrollment |
Σ | 0..* | Reference(Group) | Inclusion & exclusion criteria | ||||
| period |
Σ | 0..1 | Period | When the study began and ended | ||||
| sponsor |
Σ | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study | ||||
| principalInvestigator |
Σ | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study | ||||
| site |
Σ | 0..* | Reference(Location) | Facility where study activities are conducted | ||||
| reasonStopped |
Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely. | ||||
| note |
0..* | Annotation | Comments made about the study | |||||
 arm |
0..* | BackboneElement | Defined path through the study for a subject | |||||
 id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name |
1..1 | string | Label for study arm | |||||
| type |
0..1 | CodeableConcept | Categorization of study arm | |||||
| description |
0..1 | string | Short explanation of study path | |||||
 objective |
0..* | BackboneElement | A goal for the study | |||||
 id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name |
0..1 | string | Label for the objective | |||||
| type |
0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective. | |||||
| Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.language | Base | preferred | Common Languages | 📍4.0.1 | FHIR Std. |
| ResearchStudy.status | Base | required | ResearchStudyStatus | 📍4.0.1 | FHIR Std. |
| ResearchStudy.primaryPurposeType | Base | extensible | ResearchStudyPrimaryPurposeType | 📍4.0.1 | FHIR Std. |
| ResearchStudy.phase | Base | example | ResearchStudyPhase | 📍4.0.1 | FHIR Std. |
| ResearchStudy.category | Base | example | Not State | Unknown | |
| ResearchStudy.focus | Base | example | Not State | Unknown | |
| ResearchStudy.condition | Base | example | Condition/Problem/Diagnosis Codes | 📍4.0.1 | FHIR Std. |
| ResearchStudy.keyword | Base | example | Not State | Unknown | |
| ResearchStudy.location | Base | extensible | Jurisdiction | 📍4.0.1 | FHIR Std. |
| ResearchStudy.reasonStopped | Base | example | ResearchStudyReasonStopped | 📍4.0.1 | FHIR Std. |
| ResearchStudy.objective.type | Base | preferred | ResearchStudyObjectiveType | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource |
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from ResearchStudy
Key Elements View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| ResearchStudy |
0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |
| meta |
Σ | 0..1 | Meta(2.0.0) | Metadata about the resource |
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created |
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored |
| status |
?!Σ | 1..1 | code | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. |
| Documentation for this format | ||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.status | Base | required | ResearchStudyStatus | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource |
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
Differential View
This structure is derived from ResearchStudy
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| ResearchStudy |
0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |
| meta |
0..1 | Meta(2.0.0) | Metadata about the resource | |
| Documentation for this format | ||||
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: | ||||
|---|---|---|---|---|---|---|---|---|
| ResearchStudy |
0..* | ResearchStudy | Investigation to increase healthcare-related patient-independent knowledge | |||||
| id |
Σ | 0..1 | id | Logical id of this artifact | ||||
| meta |
Σ | 0..1 | Meta(2.0.0) | Metadata about the resource | ||||
| implicitRules |
?!Σ | 0..1 | uri | A set of rules under which this content was created | ||||
| language |
0..1 | code | Language of the resource content Binding: CommonLanguages (preferred): A human language.
| |||||
| text |
0..1 | Narrative | Text summary of the resource, for human interpretation This profile does not constrain the narrative in regard to content, language, or traceability to data elements | |||||
| contained |
0..* | Resource | Contained, inline Resources | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?! | 0..* | Extension | Extensions that cannot be ignored | ||||
| identifier |
Σ | 0..* | Identifier | Business Identifier for study | ||||
| title |
Σ | 0..1 | string | Name for this study | ||||
| protocol |
Σ | 0..* | Reference(PlanDefinition) | Steps followed in executing study | ||||
| partOf |
Σ | 0..* | Reference(ResearchStudy) | Part of larger study | ||||
| status |
?!Σ | 1..1 | code | active | administratively-completed | approved | closed-to-accrual | closed-to-accrual-and-intervention | completed | disapproved | in-review | temporarily-closed-to-accrual | temporarily-closed-to-accrual-and-intervention | withdrawn Binding: ResearchStudyStatus (required): Codes that convey the current status of the research study. | ||||
| primaryPurposeType |
Σ | 0..1 | CodeableConcept | treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility Binding: ResearchStudyPrimaryPurposeType (extensible): Codes for the main intent of the study. | ||||
| phase |
Σ | 0..1 | CodeableConcept | n-a | early-phase-1 | phase-1 | phase-1-phase-2 | phase-2 | phase-2-phase-3 | phase-3 | phase-4 Binding: ResearchStudyPhase (example): Codes for the stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation. | ||||
| category |
Σ | 0..* | CodeableConcept | Classifications for the study Binding Description: (example): Codes that describe the type of research study. E.g. Study phase, Interventional/Observational, blinding type, etc. | ||||
| focus |
Σ | 0..* | CodeableConcept | Drugs, devices, etc. under study Binding Description: (example): Codes for medications, devices and other interventions. | ||||
| condition |
Σ | 0..* | CodeableConcept | Condition being studied Binding: Condition/Problem/DiagnosisCodes (example): Identification of the condition or diagnosis. | ||||
| contact |
Σ | 0..* | ContactDetail | Contact details for the study | ||||
| relatedArtifact |
0..* | RelatedArtifact | References and dependencies | |||||
| keyword |
Σ | 0..* | CodeableConcept | Used to search for the study Binding Description: (example): Words associated with the study that may be useful in discovery. | ||||
| location |
Σ | 0..* | CodeableConcept | Geographic region(s) for study Binding: Jurisdiction ValueSet (extensible): Countries and regions within which this artifact is targeted for use. | ||||
| description |
0..1 | markdown | What this is study doing | |||||
| enrollment |
Σ | 0..* | Reference(Group) | Inclusion & exclusion criteria | ||||
| period |
Σ | 0..1 | Period | When the study began and ended | ||||
| sponsor |
Σ | 0..1 | Reference(Organization) | Organization that initiates and is legally responsible for the study | ||||
| principalInvestigator |
Σ | 0..1 | Reference(Practitioner | PractitionerRole) | Researcher who oversees multiple aspects of the study | ||||
| site |
Σ | 0..* | Reference(Location) | Facility where study activities are conducted | ||||
| reasonStopped |
Σ | 0..1 | CodeableConcept | accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design Binding: ResearchStudyReasonStopped (example): Codes for why the study ended prematurely. | ||||
| note |
0..* | Annotation | Comments made about the study | |||||
| arm |
0..* | BackboneElement | Defined path through the study for a subject | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name |
1..1 | string | Label for study arm | |||||
| type |
0..1 | CodeableConcept | Categorization of study arm | |||||
| description |
0..1 | string | Short explanation of study path | |||||
| objective |
0..* | BackboneElement | A goal for the study | |||||
| id |
0..1 | string | Unique id for inter-element referencing | |||||
| extension |
0..* | Extension | Additional content defined by implementations | |||||
| modifierExtension |
?!Σ | 0..* | Extension | Extensions that cannot be ignored even if unrecognized | ||||
| name |
0..1 | string | Label for the objective | |||||
| type |
0..1 | CodeableConcept | primary | secondary | exploratory Binding: ResearchStudyObjectiveType (preferred): Codes for the kind of study objective. | |||||
| Documentation for this format | ||||||||
| Path | Status | Usage | ValueSet | Version | Source |
| ResearchStudy.language | Base | preferred | Common Languages | 📍4.0.1 | FHIR Std. |
| ResearchStudy.status | Base | required | ResearchStudyStatus | 📍4.0.1 | FHIR Std. |
| ResearchStudy.primaryPurposeType | Base | extensible | ResearchStudyPrimaryPurposeType | 📍4.0.1 | FHIR Std. |
| ResearchStudy.phase | Base | example | ResearchStudyPhase | 📍4.0.1 | FHIR Std. |
| ResearchStudy.category | Base | example | Not State | Unknown | |
| ResearchStudy.focus | Base | example | Not State | Unknown | |
| ResearchStudy.condition | Base | example | Condition/Problem/Diagnosis Codes | 📍4.0.1 | FHIR Std. |
| ResearchStudy.keyword | Base | example | Not State | Unknown | |
| ResearchStudy.location | Base | extensible | Jurisdiction | 📍4.0.1 | FHIR Std. |
| ResearchStudy.reasonStopped | Base | example | ResearchStudyReasonStopped | 📍4.0.1 | FHIR Std. |
| ResearchStudy.objective.type | Base | preferred | ResearchStudyObjectiveType | 📍4.0.1 | FHIR Std. |
| Id | Grade | Path(s) | Description | Expression |
| dom-2 | error | ResearchStudy | If the resource is contained in another resource, it SHALL NOT contain nested Resources |
contained.contained.empty()
|
| dom-3 | error | ResearchStudy | If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource |
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
|
| dom-4 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated |
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
|
| dom-5 | error | ResearchStudy | If a resource is contained in another resource, it SHALL NOT have a security label |
contained.meta.security.empty()
|
| dom-6 | best practice | ResearchStudy | A resource should have narrative for robust management |
text.`div`.exists()
|
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children |
hasValue() or (children().count() > id.count())
|
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both |
extension.exists() != value.exists()
|
This structure is derived from ResearchStudy
Other representations of profile: CSV, Excel, Schematron